Teva files new FDA petition against generic Copaxone


Teva is battling against possible generic competition from September for the multiple sclerosis treatment.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has filed another citizen's petition with the US Food and Drug Administration (FDA) against planned generic versions of its multiple sclerosis treatment Copaxone. On each of the previous seven occasions that Teva filed such a petition, the FDA ruled that it was too early to discuss such a matter.

The latest petition was filed at the end of last week in line with FDA instructions that any new Teva research data on Copaxone must be made public.

Copaxone is Teva's most profitable medication with sales of $4.2 billion in 2014. The company is readying for the possibility of generic competition by September, but continues to fight on the issue, among other things through FDA petitions.

Citi analyst Liav Avraham does not see generic competition for Teva in the immediate future follow discussions with Synthon, which is developing a generic version of Copaxone.

Published by Globes [online], Israel business news - - on April 5, 2015

© Copyright of Globes Publisher Itonut (1983) Ltd. 2015

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